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Manufacturing and Marketing OTC Drugs in Compliance with FDA Regulations

4 - 5 June 2015, Chicago, United States

Introduction

Course Description:

This interactive one and a half day seminar is intended to help companies understand the legal definitions of cosmetics, drugs, dietary supplements and why certain labeling statements for non-drug products may cause the agency to consider them new drugs without FDA approval.

The instructor, a leading industry expert and former FDA official, will explain differences in the way homeopathic and conventional drugs are regulated and how the risks presented by different types of drug products affect the rigor of FDA enforcement of Good Manufacturing Practices Regulations. A workshop will be held at the finale of the course to emphasize certain issues by having participants review labels of misbranded products and examples of recent FDA Warning Letters.

The seminar will address issues such as:

How both labeling and advertising establishes ‘intended use’ which defines a product?When cosmetics, dietary supplements and foods might become drugs requiring FDA approval?How OTC drug monographs can help one to formulate products and design labels?Why are OTC drug/cosmetic combinations (cosmeceuticals) allowed, but not OTC drug/dietary supplement combinations?What are common personal care product ingredients that have both cosmetic and drug uses?The restriction on combining allopathic and homeopathic ingredients in a drug formula.Things that one needs to know when designing labels:Creative product names can cause a product to be misbranded.Proper formatting of Drug Facts boxed panels.Type size requirements and placement of information on principal display panels.Changes FDA now believes may be needed in monograph content and in changing monographs.

Learning Objectives:

Understand FDA regulations and policies regarding manufacturing and labeling of OTC drugs covered by OTC drug monographs (minimal information is provided to contrast the new drug approval process).Learn the definitions of drug, cosmetic, and dietary supplements.Obtain tips on how to research FDA’s OTC drug monograph rulemakings.What labeling other than labels can define a product and cause it to be misbranded as a new drug.Learn that certain ingredients are safe and suitable for use in both drugs and cosmetics.Differentiate cosmetic ‘puffery’ claims from claims that FDA would likely consider drug claims.Learn how to formulate and label cosmeceuticals (cosmetics which are also drugs).Understand the differences in how allopathic (conventional) drugs and homeopathic drugs are regulated.Learn the basic requirements for marketing homeopathic OTC drugs.Recognize ways to manufacture low health risk products at minimum cost, yet still meet the intent and basic requirements of GMP regulations.Learn how to minimize the regulatory risk of a Warning Letter or other FDA action.

Note: Use coupon code 232082 and get 10% off on registration.

Speakers

Bill SchwemerPrincipal, Schwemer Consulting and Former Senior FDA & Industry OfficialBill Schwemer is an ex-FDA official with more than 50 years’ experience in FDA compliance matters. He was an FDA field investigator and compliance officer in two districts. As director, division of field investigations, he managed the FDA foreign inspection program and his staff supported the district investigations branches. He was a senior official in FDA's Office of the Commissioner in both the Offices of Regulatory Affairs and Policy. His industry experience includes V-P of RA/QA at a personal care products company and consulting for businesses nationwide and in Europe and Asia. His consulting business in recent years has been primarily for pharmaceutical and personal care products companies. He has published more than 125 articles and since becoming a consultant has successfully served as a regulatory compliance expert witness in 22 lawsuits.

In his FDA Office of Regulatory Affairs positions, Mr. Schwemer had insights on all current OTC Drug Compliance Policy Guides (CPGs) and approved either original drafts or revisions on behalf of the office. Recently, he petitioned FDA to revise the CPG “Conditions Under Which Homeopathic Drugs May be Marketed.”, United States